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The GaltTWS Stylet is a percutaneous catheter stylet placed inside a catheter, lead, or cannula to stiffen the device for placement or extraction.

The GaltTWS stylet is comprised of a stainless steel twisted/braided wire of varying diameters (0.012-0.015 inch), and varying length (30-72cm). The GaltTWS stylet can be configured as a Twisted/Braided wire bonded to a hub, flushable hub, or connected to a flushable adjustable hub using the Galt Gateway Hemostasis Valve (K152528).

This document is a 510(k) premarket notification decision letter for a medical device called the "GaltTWS Stylet." As such, it does not contain the information requested regarding acceptance criteria and the study proving the device meets those criteria in the context of an AI/ML-based medical device.

The requested information (acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, etc.) is specific to studies proving the performance of AI/ML algorithms. This FDA letter pertains to a non-AI medical device (a catheter stylet) and focuses on demonstrating substantial equivalence to predicate devices through bench testing and biocompatibility.

Therefore, I cannot fulfill the request using the provided text. The document describes:

• Device: GaltTWS Stylet (a percutaneous catheter stylet)
• Purpose: Stiffen a catheter, lead, or cannula for placement or extraction.
• Regulatory Pathway: 510(k) for substantial equivalence.
• Testing: Bench testing (Particulate, Mechanical Properties, Leak, Tortuous Path) and Biocompatibility testing (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Hemolysis, Pyrogen, EO Residuals).
• Conclusion: Device is substantially equivalent to marketed predicate devices.

This information is relevant to traditional medical device clearance, not the evaluation of AI/ML performance.

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